Effect of Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure (CKD) (SIR)

Karolinska Institute

Status: Withdrawn

Conditions: End-Stage Renal Disease; Insulin Resistance; Hyperphosphatemia; Kidney Failure, Chronic

Treatments: Drug: Calcium carbonate; Drug: Sevelamer

Study type: Interventional

Funder types: Other

Identifiers

NCT00837655

SIR_CT_CLINTEC_01

Details and patient eligibility

About

The purpose of this study is to perform a randomized, controlled clinical trial to investigate if the phosphate binder sevelamer can improve insulin resistance and glucose handling in patients receiving maintenance hemodialysis.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients 18-80 years of age with chronic renal failure treated with maintenance HD for >3 months.

Exclusion criteria

• Diabetes mellitus
• Treatment with sevelamer within 3 months prior to enrollment
• Acute, clinically significant inflammation within 1 month prior to enrollment
• Pregnancy or breast-feeding
• Clinically significant obstipation or bowel obstruction
• Discontinuation of previous sevelamer treatment because of side effects
• Expected time in HD < 1 year
• Unwillingness to undergo the investigations and follow-up required in the the protocol
• Patients who have received any investigational drug within 1 month prior to enrolment
• Participation in another study, which may interfere with the present study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

1

Experimental group

Description:

Sevelamer intervention

Treatment:

Drug: Sevelamer

2

Active Comparator group

Description:

Calcium carbonate

Treatment:

Drug: Calcium carbonate